Global Clinical Sample Challenges — New Strategies for Molecular Testing & Flow Cytometry Panel Development

Join this webinar to hear the featured speakers address global clinical sample challenges, with a focus on logistical considerations, new strategies for molecular testing and flow cytometry panel development.

Logistical/Operational Considerations:

Clinical trials and investigational products are becoming more complex, such as within the field of cell and gene therapy, and so is the bioanalytical testing of patient samples. For example, clinical sample analysis plans evaluating safety and efficacy of allogeneic gene-modified cell therapies may encompass over 25 bioanalytical assessments on patient samples, mainly falling within the following categories:

• PK
• PD
• Tumor burden
• Safety
• Immunogenicity

Such complex sample analysis plans necessitate diligent sample management and processing procedures, as well as careful selection of the most appropriate downstream testing methods and platforms especially considering that patient samples are limited. For example, components of one whole blood sample may be needed for multiple bioanalytical assessments at different laboratories. This single sample’s collection tube, transport conditions and processing procedure must all meet the requirements for each downstream analysis. LabConnect’s sample processing, sample tracking and scientific support services work cross-functionally with partner labs around the world to ensure samples meet all testing requirements.

Flow Challenges:

Flow cytometry is a powerful tool in drug development. The complexity of these assays will continue to evolve as new instrumentation and data analysis packages become available. In clinical trials, flow cytometry analyses provide deep interrogation of cell populations. Therefore, it is critical to develop highly adaptable panels to meet the unique challenges of global trials. When developing a panel, thought must be given to potential trial locations, clinical sample matrices and volume, logistical considerations, CRO (Contract Research Organizations) constraints and level of development and/or validation required. Highly flexible panels that consist of a validated backbone in multiple matrices and adaptable add-on packages to interrogate specific populations of interest are an efficient and cost-effective method that will provide quality, consistent and comparable reportable readouts across drug development programs.

Molecular Testing:

Molecular testing is another powerful tool often utilized across many clinical sample types to help drive clinical research. While sample processing is important for these analyses, so too is selection of the downstream technology itself. Next-generation sequencing (NGS), RNA-sequencing (RNA-seq) using NGS, quantitative polymerase chain reaction (qPCR) and digital droplet PCR (ddPCR) are frequently used to evaluate impacts of investigational products and measure endpoints in clinical trials. Each technology’s benefits and limitations must be considered along with the data that will be generated when deciding which is most appropriate for a specific molecular analysis. LabConnect’s technical experts work with scientists at partner labs when evaluating approaches to ensure the needs of study sponsors are met.

Speakers

Joseph Marino, Sr Director, Scientific Operations, LabConnect

Joseph Marino is the Senior Director of FSP Solutions at LabConnect. Joe brings over 18 years of experience in managing complex analytical testing profiles and research vendors for the development of novel therapeutics. He is responsible for leading a team of scientists, sample management professionals and contract managers strategically supporting clients within the pharmaceutical industry. He also has extensive experience in leading activities in method development and validation, process development, quality control and analytical lifecycle management. During his time at LabConnect, Joe has been responsible for the scientific oversight and clinical phase project management of numerous pharmaceutical products. In addition to his analytical expertise, Joe has specialized in the development of processes to standardize collection and isolation procedures for blood derived components. Joe holds a BS in microbiology from Washington State University and an MS in microbiology from the University of Hawaii.

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Dr. Loren Blake, MD, Study Director, Scientific Operations, LabConnect

Dr. Loren Blake serves as Study Director with the FSP Solutions leadership team at LabConnect. She is a physician and scientist with a background in cell & gene therapy, experienced in medical & scientific affairs and clinical development. Serving at a strategic level at LabConnect, she collaborates with clinical study sponsors and partner labs to plan approaches to bioanalytical testing and mitigate potential risks, while providing subject matter expertise on biomarker assays, method development, validation and technical transfer to ensure scientific integrity and adherence to study protocols and regulatory requirements for clinical research trials.

Dr. Blake received her medical degree from New York Medical College before postdoctoral training in internal medicine at Montefiore New Rochelle and additional residency training in Diagnostic Radiology at Westchester Medical Center. She received her master’s degree in medical sciences from Boston University, performing cancer immunotherapy research at Dana-Farber Cancer Institute’s Division of Medical Oncology, Hematologic Neoplasia.

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Rebecca McKee, Sr Scientific Project Manager, LabConnect

Rebecca McKee serves as Senior Project Manager and is a subject matter expert for Flow Cytometry and Biomarker Project Management as part of the LabConnect Functional Service Provider (FSP) Solutions team. In her current role, Becca works collaboratively with sponsors to provide exceptional oversight of outsourced method development, validation and data analysis for preclinical and clinical trial protocols. She holds a master’s degree in biotechnology from Johns Hopkins University and has been working in various capacities in the industry for over 10 years supporting drug development. She is experienced in developing and validating a variety of techniques for biomarker, pharmacodynamic and immunogenicity methods to assess critical and exploratory endpoints to support preclinical and clinical trial programs.

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